Compliance with 21 CFR, Part 820 (the FDA’s Quality System Regulation) is not optional for device manufacturers wanting to enter medical devices into commerce in the United States. Compliance is driven, in part, by device classification (three device classes in the U.S.). However, many device manufacturers entering products into commerce for the first time struggle to understand what is actually required for compliance.
If your organization is struggling with understanding the salient requirements associated with 21 CFR, Part 820, this webinar is for you. This webinar will help your organizations better understand the FDA’s expectations for implementing a Quality Management System (QMS), while providing insight into tools needed for establishing an effective approach to quality management. For establishments already having a compliant QMS, this webinar will help your organization streamline their approach to Quality Management.
Areas to be Covered:
Reviewing and understanding the requirements associated with 21 CFR, Part 820 compliance.
Regulatory and statutory requirements.
Similarities with ISO 13485:2003.
Establishing QMS processes and procedures.
Documented evidence of compliance.
The importance of procedures and record collection.
Employing CAPA to drive QMS improvements.
The FDA’s inspection process.
Form 483 – inspectional observations.
The FDA Warning Letter process.
Who will Benefit:
A must attend webinar for all industry professionals, regardless of functional roles, will benefit from this training, especially if you are involved in the day-to-day activities associated with supporting your organization’s QMS. The staff who will benefit include:
R & D Engineers